Curosurf (poractant alfa) 240 mg Intratracheal Suspension
Chiesi USA is recalling Curosurf 240 mg intratracheal suspension vials (NDC 10122-510-03) due to lack of sterility assurance.
Do not use this product. Contact Chiesi USA, Inc. immediately for instructions on return or disposal. Consult your healthcare provider regarding alternative treatment options.
Why it was recalled
Chiesi USA, Inc. is recalling Curosurf (poractant alfa) 240 mg Intratracheal Suspension, 3 mL single-dose vials (NDC 10122-510-03) due to lack of assurance of sterility. The affected product was distributed nationwide. Sterility assurance is critical for intratracheal medications administered directly to the lungs.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
- Recall #
- D-0402-2026
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Chiesi USA, Inc.
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification